Core 2: Biostatistics and Bioinformatics SUMMARY/ABSTRACT All projects in this Ovarian SPORE generate large amounts of data using a wide variety of assays, and are associated with clinical trials testing the efficacy of new therapeutic options. The Biostatistics and Bioinformatics Core (Core 2) provides the quantitative expertise required to distill useful information from these various types of data, and to design and analyze the data from the clinical trials being run. Neither of these tasks is trivial. Assays now available (e.g., next-generation sequencing for mutation analysis, methylation arrays for epigenetic studies, expression arrays) are extremely powerful and can detect subtle changes that may be driving phenotypic changes, but this very sensitivity means they are also quite capable of detecting assay artifacts if proper experimental design (e.g., randomization) is not used. Further, the raw data generated requires substantial preprocessing before valid inferences can be drawn. Members of Core 2 have the training to address these tasks, which are common to the various projects?many of the same assays are being used with different experimental goals in mind, but the data analytic questions are parallel. Similarly, while all clinical trials have common goals (dose finding, treatment assessment), explicitly specifying what must be done to produce trials likely to provide the most information while putting the fewest patients at risk requires expertise in both the elicitation of relevant information and the ability to examine likely outcomes (often through simulation). Some common designs exist for the most frequent approaches pursued, but recent advances in the past few decades have allowed us to develop new strategies that may be better suited to the tasks at hand where the computing power now exists to explore how the operating characteristics are improved. Providing optimal support for the projects also requires the flexibility to address new challenges and opportunities that may arise. In this iteration of the SPORE, some of these challenges and opportunities include trying to optimally exploit both (a) data uniquely available within MD Anderson, where coupling of laparoscopic examination and biopsies with surgical evaluation lets us acquire both pre- and post-treatment samples from the population of interest, and (b) the wealth of public profiling data (e.g. TCGA ovarian assays) which can help winnow real phenomena from chaff. Core 2 has this flexibility, and is working with SPORE investigators on these tasks even now. Further, as the studies being pursued in the SPORE show, the separation between complex assays and clinical trials is becoming increasingly blurred. Moving forward will require clear thinking about what types of inferences can be reliably used, and how. Members of Core 2 are widely recognized for their contributions to this debate, which enables them to better support the SPORE.